CICATRISAN CREAM- calendula officinalis, phytolacca decandra, bryonia dioica, balsamum peruvianum, dulcamara cream

CICATRISAN Cream by

Drug Labeling and Warnings

CICATRISAN Cream by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN'UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
This preparation contains:
Balsamum peruvianum
(Peruvian balsam) Balsam MT 1.0%
Bryonia dioica (Red bryony)
Root MT 1.0%
Calendula officinalis
(Marigold) Aerial Parts MT 1.0%
Dulcamara (Bittersweet)
Shoots MT 1.0%
Phytolacca decandra
(Pokeweed) Root MT 1.0%

PURPOSE

Uses
For the temporary relief of symptoms
associated with minor skin irritations.

WARNINGS

Warnings
For external use only.
Stop use and ask a doctor if symptoms
persist or worsen.
If pregnant or breastfeeding, ask a
health professional before use. Keep out
of reach of children. If swallowed, get
medical help or contact a Poison Control
Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

If swallowed, get medical help or contact a Poison
Control Center right away.

INACTIVE INGREDIENT

Inactive ingredients
Boric acid, mineral oil, sorbitan
sesquioleate, white petrolatum

DOSAGE & ADMINISTRATION

Directions
Adults: Apply a small amount on the
affected area two to three times daily, or as
recommended by your healthcare
practitioner. May cover affected area with
sterile gauze after each application.
Children: Use under the direction of your
healthcare practitioner.

INDICATIONS & USAGE

Uses
For the temporary relief of symptoms
associated with minor skin irritations.

Directions
Adults: Apply a small amount on the
affected area two to three times daily, or as
recommended by your healthcare
practitioner. May cover affected area with
sterile gauze after each application.
Children: Use under the direction of your
healthcare practitioner.

OTHER SAFETY INFORMATION

Other information
Do not use if inner seal is missing or
broken.
Store in a cool, dry place.

PRINCIPAL DISPLAY PANEL

NDC: 62106-3152-0

UNDA topicals

CICATRISAN CREAM

Homeopathic Preparation

For the temporary relief of symptoms
associated with minor skin irritations.

Net Weight 1.4 oz. (40 g)

INGREDIENTS AND APPEARANCE

CICATRISAN CREAM 
calendula officinalis, phytolacca decandra, bryonia dioica, balsamum peruvianum, dulcamara cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-3152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BALSAM PERU (UNII: 8P5F881OCY) (BALSAM PERU - UNII:8P5F881OCY)	BALSAM PERU	1 [hp_X]  in 40 g
BRYONIA DIOICA ROOT (UNII: 53UB5FH7CX) (BRYONIA DIOICA ROOT - UNII:53UB5FH7CX)	BRYONIA DIOICA ROOT	1 [hp_X]  in 40 g
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N)	SOLANUM DULCAMARA TOP	1 [hp_X]  in 40 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 40 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	1 [hp_X]  in 40 g

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
PARAFFIN (UNII: I9O0E3H2ZE)
MINERAL OIL (UNII: T5L8T28FGP)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-3152-0	1 in 1 CARTON	05/07/2015
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/07/2015

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN'UP		401010287	manufacture(62106-3152)